RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

3,400 total clearances

Transorb™ Self-Gripping Resorbable Mesh

Sofradim Production

ONE-CUF

Ge Medical Systems Information Technologies, Inc.

VS3-Iridium System (VS3-IR)

Visionsense, Ltd.

ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

Luminance Red Cold Sore Device (TN1927G)

Luminance Medical Ventures, Inc.

ArtiSential Laparoscopic Instruments-Electrodes

Livsmed, Inc.

BD Nano 2nd Gen Pen Needle

Becton, Dickinson and Company

aprevo® Digital Segmentation

Carlsmed, Inc.

da Vinci SP Surgical System

Intuitive Surgical, Inc.

prodisc® L Instruments

Centinel Spine, LLC

NxStage PureFlow Solution

Nxstage Medical, Inc.

iFuse Bedrock Granite Implant System

SI-BONE, Inc.

SQA-iO Sperm Quality Analyzer

Medical Electronic Systems , Ltd.

MR 5300

Philips Medical Systems Nederland B.V.

CVAC® Aspiration System

Calyxo, Inc.

Oxygen Concentrator (J5A)

Foshan Kycare Medical Equipment Co., Ltd.

Navilas Laser System 577sl (156691)

Od-Os GmbH

Annalise Enterprise CTB Triage-OH

Annalise-Ai Pty , Ltd.

T-Line® Hernia Mesh

Deep Blue Medical Advances, Inc.

TnR Cranial Implant

T&R BIOFAB CO., Ltd.

NightOwl

Ectosense NV

Trigon PEEK HA Wedges

Nvision Biomedical Technologies

AlphaVac Multipurpose Mechanical Aspiration System F1885

AngioDynamics, Inc.

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

CMT Health PTE., Ltd.

Sunny Cup and Applicator

Menstrual Mates

APTUS Elbow Dorsal Olecranon Plates

Medartis AG

Signature Osteosynthesis Plate System

Signature Orthopaedic Pty , Ltd.

Control-IQ+ technology

Tandem Diabetes Care, Inc.

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Teleport XT Microcatheter

OrbusNeich Medical (Shenzhen) Co., Ltd.

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